B Braun Medical recalled 41,976 IV administration sets on October 29, 2025. The recall stems from a risk of medication backflow into primary IV containers. Affected products include catalog number 490354, distributed worldwide.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
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The recall involves IV Administration Set with catalog number 490354. The product is part of gravity IV and pump administration systems. It has a primary UDI-DI of 04046964602382.
The recalled IV administration sets pose a high hazard risk due to potential backflow of medication. This backflow can occur from secondary IV containers into primary containers, compromising patient safety.
No specific incidents or injuries have been reported yet. The recall reflects a proactive measure to prevent potential harm.
Healthcare providers and patients must stop using the device immediately. Follow the recall instructions from B Braun Medical for further guidance.
For more details, contact B Braun Medical Inc. Visit the FDA recall page for updates and instructions.
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